Using 100 fresh blood samples from NHS Tayside septic patients, this project aims to evaluate, in collaboration with the Universities of St Andrews and Dundee, and the National Infectious Disease Institute, iSEP-SEQ's overall performance and clinical applicability in the rapid near-patient identification of pathogens from non-cultured blood samples. The National Measurement Laboratory, the UK’s designated institute for chemical and bio-measurements, will provide robust statistical analysis and oversight on the validation and method performance for future regulatory approval.
In addition to receiving over £1.4 million in grant funding to date, this project has received support from the Global Sepsis Alliance, the UK Sepsis Trust, Sheikh Shakhbout Medical City, The University of Edinburgh, UniverstatsMedizin Mainz (Germany), Aichi Medical University (Japan), National Institute of Infectious Diseases (NIID, Japan), Public Health Scotland, and Oxford Nanopore, who will bring in the patient voice, additional clinical perspectives and technical support to the project.
The iSEP-SEQ approach will bring unbiased large-range pathogen identification to the clinic and aid timely medical decisions by identifying any class of microorganism present in the sample, including bacteria, fungi, parasites and viruses.
iSEP-SEQ aligns strongly with the UK Health Security Agency's 5-year Pathogen Genomics Strategy published in January 2024, specifically with Strategic Aim 1 and Strategic Aim 6: The emphasis on utilizing genomic data for informed decision-making in clinical and public health, as well as driving innovation in pathogen genomics, is crucial for effectively addressing and responding to public health threats. The support from Public Health Scotland further underscores the significance of iSEP-SEQ in contributing to these strategic aims. iSEP-SEQ has the potential to transform sepsis, febrile and acute disease diagnosis, reduce patient morbidity and mortality, and combat antimicrobial resistance.